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| Sponsored by: |
Applied Molecular Evolution |
| Information provided by: | Applied Molecular Evolution |
| ClinicalTrials.gov Identifier: | NCT00354926 |
Purpose
The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients, but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells. A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody. This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
| Condition | Intervention | Phase |
|
Non-Hodgkin's Lymphoma |
Drug: AME-133v (LY2469298) |
Phase I Phase II |
| MedlinePlus related topics: | Lymphoma |
| ChemIDplus related topics: | Rituximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY 2469298), Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in the study protocol, subjects have to meet all of the following criteria.
Have adequate hematopoietic, renal, and hepatic function defined as:
Exclusion Criteria:
Subjects with any of the following exclusions are not allowed to participate in the study.
Contacts and Locations| Contact: Susan Carpenter, PhD | 858-597-4990 | carpentersu@lilly.com |
| United States, Alabama | |||||
| University of Alabama Medical Center | Recruiting | ||||
| Birmingham, Alabama, United States, 35249 | |||||
| Contact: Alma DelGrosso, RN, OCN, CCRP 205-934-0337 alma.delgrosso@ccc.uab.edu | |||||
| Principal Investigator: Andres Forero-Torres, MD | |||||
| United States, California | |||||
| UCLA Medical Hematology and Oncology | Recruiting | ||||
| Los Angeles, California, United States, 90095 | |||||
| Contact: Shu-Shanna Dixon 310-825-3459 ssdixon@mednet.ucla.edu | |||||
| Principal Investigator: Sven de Vos, M.D., Ph.D. | |||||
| Stanford University Medical Center | Recruiting | ||||
| Stanford, California, United States, 94305 | |||||
| Contact: Julia Dugay, MD 650-725-6413 jdugay@stanford.edu | |||||
| Principal Investigator: Kristen Ganjoo, MD | |||||
| United States, Illinois | |||||
| Rush University Medical Center | Recruiting | ||||
| Chicago, Illinois, United States, 60612 | |||||
| Contact: Wendy Mallon, RN, BSN, OCN 312-563-2140 wendy_mallon@rush.edu | |||||
| Principal Investigator: Stephanie A. Gregory, MD | |||||
| United States, Iowa | |||||
| University of Iowa | Recruiting | ||||
| Iowa City, Iowa, United States, 52242 | |||||
| Contact: Mary Shannon 319-356-3516 mary-shannon@uiowa.edu | |||||
| Principal Investigator: Brian Link, M.D. | |||||
| United States, Nevada | |||||
| Nevada Cancer Institute | Recruiting | ||||
| Las Vegas, Nevada, United States, 89135 | |||||
| Contact: Christine Zades 702-822-5456 czades@nvcancer.org | |||||
| Principal Investigator: Nam Dang, MD | |||||
| United States, Ohio | |||||
| Cleveland Clinic Foundation | Recruiting | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| Contact: Stacy Mathews 216-445-6470 MATHEWS@ccf.org | |||||
| Contact: Randall Davis 216.444.9270 davisr5@ccf.org | |||||
| Principal Investigator: Brad Pohlman, MD | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| Contact: Linda Thibodeau 215-728-2207 linda.thibodeau@fccc.edu | |||||
| Principal Investigator: Mitchell R. Smith, MD, PhD | |||||
| University of Pittsburgh Medical Center | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15232 | |||||
| Contact: Patricia Schaefer, RN, BSN 412-623-4881 schaeferpm@upmc.edu | |||||
| Principal Investigator: Kenneth Foon, MD | |||||
| United States, Tennessee | |||||
| Sarah Cannon Research Institute | Recruiting | ||||
| Nashville, Tennessee, United States, 37203 | |||||
| Contact: Carla Mazzone 615-329-7274 | |||||
| Principal Investigator: Ian W. Flinn, MD, PhD | |||||
| United States, Virginia | |||||
| University of Virginia Health System | Recruiting | ||||
| Charlottesville, Virginia, United States, 22908 | |||||
| Contact: Susan Hamil, RN, BSN, OCN 434-924-5254 shs3s@virginia.edu | |||||
| Principal Investigator: Michael E. Williams, MD | |||||
| Applied Molecular Evolution |
| Principal Investigator: | Brian Link, MD | University of Iowa |
| Principal Investigator: | Andres Forero-Torres, MD | University of Alabama Medical Center |
| Principal Investigator: | Nam Dang, MD | Nevada Cancer Institute |
| Principal Investigator: | Sven de Vos, MD, PhD | University of California, Los Angeles |
| Principal Investigator: | Kristen Ganjoo, MD | Stanford University |
| Principal Investigator: | Brad Pohlman, MD | The Cleveland Clinic |
| Principal Investigator: | Mitchell R. Smith, MD, PhD | Fox Chase Cancer Center |
| Principal Investigator: | Michael E. Williams, MD | University of Virginia Health Systems |
| Principal Investigator: | Ian Flinn, MD, PhD | Sarah Cannon Research Institute |
| Principal Investigator: | Kenneth Foon, MD | University of Pittsburgh |
| Principal Investigator: | Stephanie A. Gregory, MD | Rush University Medical Center |
More Information
| Study ID Numbers: | AME 06.133v.A |
| First Received: | July 18, 2006 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00354926 |
| Health Authority: | United States: Food and Drug Administration |
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